Enalapril Maleate description, usages, side effects, indications, overdosage, supplying and lots more!

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Enalapril Maleate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus.


ENALAPRIL MALEATE DESCRIPTION


Enalapril Maleate




CLINICAL PHARMACOLOGY

Mechanism of Action





PHARMACOKINETICS AND METABOLISM








PHARMACODYNAMICS AND CLINICAL EFFECTS



























SURVIVAL (%)








INDICATIONS & USAGE


Hypertension


Heart Failure

Asymptomatic Left Ventricular Dysfunction






ENALAPRIL MALEATE CONTRAINDICATIONS



WARNINGS

Anaphylactoid and Possibly Related Reactions


Head and Neck Angioedema:Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., Subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided.







Hypotension





Neutropenia/Agranulocytosis

Hepatic Failure

Fetal/Neonatal Morbidity and Mortality









PRECAUTIONS


General









Evaluation of patients with hypertension or heart failure should always include assessment of renal function.








INFORMATION FOR PATIENTS












DRUG INTERACTIONS










CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY



NURSING MOTHERS



PEDIATRIC USE




ENALAPRIL MALEATE ADVERSE REACTIONS



HYPERTENSION



HEART FAILURE




















Clinical Laboratory Test Findings







OVERDOSAGE






DOSAGE & ADMINISTRATION

Hypertension





























HOW SUPPLIED







































STORAGE AND HANDLING





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Enalapril Maleate

Enalapril Maleate

Enalapril Maleate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-562(NDC:64679-923)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE ENALAPRILAT ANHYDROUS 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
CROSPOVIDONE
MAGNESIUM STEARATE
cellulose, microcrystalline
POTASSIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
white 6 mm W;923 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-562-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2011-10-05


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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